Xorlyx

Xorlyx

salicylic acid

Manufacturer:

Xorix

Distributor:

Xorix
Full Prescribing Info
Contents
Salicylic acid.
Description
XORLYX 5: XORLYX 5 contains Salicylic Acid (5% w/w).
XORLYX 10: XORLYX 10 is a Salicylic Acid ointment contains: Salicylic acid 0.1 gram/ 1 gram (10% w/w).
XORLYX 2/XORLYX 5:XORLYX is packaged in a printed aluminium tube with standard white cap.
XORLYX 2/XORLYX 5/XORLYX 10: Topical Salicylic Acid acts as keratolytic agent.
XORLYX 20: XORLYX 20 is a Salicylic Acid Ointment contains: Salicylic acid 0.2 g/ 1 g (20% w/w).
Works by softening keratin, a protein that forms part of the skin structure. This helps to loosen the skin cells to allow removal of warts.
Indications/Uses
XORLYX 2: XORLYX 2 Salicylic Acid 2% w/w Ointment is indicated to alleviate hyperkeratotic and scaling skin conditions such as seborrhoeic dermatitis, ichtyosis, psoriasis and acne.
XORLYX 5: Xorlyx 5 Salicylic Acid 5% w/w Ointment is indicated for the treatment of hyperkeratotic and scaling skin conditions such as acne and psoriasis.
XORLYX 10: For treatment of seborrhoeic dermatitis, scalp, psoriasis and hyperkeratotic skin disorders.
XORLYX 20: XORLYX 20 Salicylic Acid 20% w/w Ointment is indicated for removal warts.
Dosage/Direction for Use
XORLYX 2/XORLYX 5: Apply sparingly to the affected skin areas twice daily, in the morning and at night until improvement occurs. Subsequently, it may then be possible to maintain improvement by less frequent application.
XORLYX 10: Apply a thin layer of XORLYX 10 Salicylic Acid 10% w/w to the affected areas, once or twice daily (in the morning and at night) until improvement occur or as directed by physician.
XORLYX 20: Follow the doctor's instruction carefully. They may differ from the general instructions in this monograph.
Before using XORLYX 20, moisten or soak the wart in warm water for about 5 minutes to help loosen and soften the treatment area. Dry thoroughly. After soaking/moisturising and before applying the treatment to the wart, use an emery board or pumice stone to carefully remove the top dead layers of skin on the affected area (avoid sharing this board/stone with others). This dead skin removal is to help the medication penetrate the skin more easily. Do not try to rub the wart off.
Protect surrounding healthy skin (for example with White Soft Paraffin or specially designed plaster). Apply a thin layer of XORLYX 20 to cover the entire warts. Be careful to apply it only to the affected area and not the surrounding skin.
The treatment may be used once or twice daily (in the morning and at night) or as directed by the doctor or pharmacist. Treatment should start as early as possible after the start of an infection. Subsequently, it may then be possible to maintain improvement by less frequent application. The patient needs to apply the medication as instructed until the warts clear up, or for up to 12 weeks or as directed by the doctor or pharmacist. If the wart persists after 12 weeks, consult the doctor.
Overdosage
Excessive prolonged use of topical preparations containing Salicylic Acid may result in symptoms of Salicyclism. If this occurs, symptomatic treatment should be initiated.
Contraindications
XORLYX 2: Unknown.
XORLYX 5/XORLYX 10/XORLYX 20: Allergic or hypersensitivity to Salicylic Acid or any other ingredient in its preparation.
It should not be used by patients with diabetes or with impaired peripheral blood circulation.
XORLYX 10/XORLYX 20: Do not use for children aged less than 2 years.
XORLYX 20: Do not use on face or on moles, birthmarks, hairy warts or on genital/anal wart.
Special Precautions
XORLYX 2/XORLYX 5: Avoid broken skin.
For external use only.
Avoid contact with mouth, eyes and mucous membranes.
If irritation or sensitization develops, discontinue treatment.
If large areas of skin are treated, the systemic absorption of topical Salicylic Acid will be enhanced and may lead to Salicylate toxicity.
When using salicylic acid preparations do not use any of the following preparations on the affected area, unless directed to do so by the doctor: Any other medicated topical agents, e.g. benzoyl peroxide, topical retinoids; Abrasive soaps and cleansers; Cosmetics or soaps that dry the skin or are designed to peel/exfoliate.
Salicylic acid may cause dermatitis. Extensive prolonged use of topical Salicylic Acid may enhance the systemic absorption and may lead to Salicylate toxicity.
XORLYX 10/XORLYX 20: For external use only.
This preparation is to be used on the skin only.
Avoid using on open wound or area of broken, inflamed or normal skin around wart and on large areas of skin.
Avoid contact with eyes, face, genitals and mucous membranes.
Salicylic acid is irritating and may cause dermatitis.
If irritation or sensitisation develops, consult the doctor. Seek medical advice if symptoms get serious/severe or persistent.
Do not use large amounts, apply this medication more often, or use it for a longer period than directed, if large areas of skin are treated for a longer period than directed, the systemic absorption of XORLYX will be enhanced and may lead to Salicylate toxicity.
Do not share the medication with others.
Be careful to apply it only to the affected area and not the surrounding skin.
When using XORLYX do not use any of the following preparations on the affected area, unless directed to do so by the doctor: Any other medicated topical agents, e.g. benzoyl peroxide, topical retinoids, salicylate and hydroquinone.
Abrasive soaps and cleansers.
Cosmetics/soaps that dry the skin or are designed to peel/exfoliate.
Protein bound drugs.
Alcohol containing preparation.
XORLYX 20: Do not share the medication with others as warts can be contagious through skin contact.
Use in Pregnancy & Lactation: XORLYX 2: The safety has not been established. Therefore, it should be used with caution or following professional advice.
Use in Children: Consult the doctor before using this treatment on children aged 2 to 12 years.
Use in Elderly: XORLYX should be used cautiously in elderly.
Use In Pregnancy & Lactation
Pregnancy Category C.
XORLYX should be used only if potential benefit outweighs the potential risk to the fetus. Topical Salicylic Acid should not be used extensively in large amount or for prolonged period in pregnant women.
XORLYX should be used cautiously in nursing mothers.
XORLYX 2: The safety has not been established. Therefore, it should be used with caution or following professional advice.
Adverse Reactions
XORLYX 2/XORLYX 5: Contact dermatitis or skin irritation; flushing; unusually warm skin.
Excessive drying and peeling of skin.
XORLYX 10/XORLYX 20: Like all medicines, XORLYX can cause unwanted side effects although not everyone gets them. Some possible effects are: Contact dermatitis or skin irritation; flushing, unusually warm skin, burning sensation; pruritus and stinging of skin.
Excessive drying and peeling of skin.
Extensive prolonged use of XORLYX may enhance the systemic absorption and may lead to Salicylate toxicity.
Drug Interactions
XORLYX 2/XORLYX 5: Other topical preparations, mainly isotretinoin, tretinoin, tazarotene.
XORLYX 10/XORLYX 20: Please tell the doctor or pharmacist if the patient is taking/using or have recently taken/used any other medicine or preparation such as: Any other medicated topical agents, e.g. benzoyl peroxide, topical retinoids, salicylate and hydroquinone.
Abrasive soaps and cleansers.
Cosmetics or soaps that dry the skin or are designed to peel/exfoliate.
Protein bound drugs.
Alcohol containing preparation.
Storage
Store below 30°C.
Keep the tube tightly closed.
Do not freeze.
Protect from heat, moisture and light.
Shelf-Life: XORLYX 2: 2 years.
XORLYX 5/XORLYX 10/XORLYX 20: 36 months.
ATC Classification
D01AE12 - salicylic acid ; Belongs to the class of other antifungals for topical use.
Presentation/Packing
Oint (white or almost white and/or translucent) 2% w/w x 15 g. 5% w/w x 15 g. 10% w/w x 15 g. 20% w/w x 15 g.
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